Panorama Patient Monitoring Network— 510(k) K142601
Substantially EquivalentShenzhen Mindray Bio-Medical Electronics Co.
FDA 510(k) clearance K142601 for Panorama Patient Monitoring Network, Substantially Equivalent on 2014-11-14. Applicant: Shenzhen Mindray Bio-Medical Electronics Co.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Nasham, CN
Recent devices under product code MHX
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K142601
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142601.
Data sourced from openFDA. This site is unofficial and independent of the FDA.